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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-400-18
Device Problems Break (1069); Retraction Problem (1536); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2020
Event Type  Injury  
Manufacturer Narrative
The pipeline flex pushwire has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the distal tip of the of the medtronic flow diverter pushwire was stuck and separated as the pushwire was being retracted into the medtronic microcatheter after it was being used for an indication that was not approved in the instructions for use (ifu) (the flow diverter was being used in an aneurysm that was previously stent coiled with lvis stent. The distal tip was removed from the patient with the use of a medtronic 6 x 40 stent retriever. It was also reported that the physician used a balloon to angioplasty the proximal portion of the medtronic flow diverter. No patient injury was reported as a result of the event. Prior to the event, the medtronic flow diverter was successfully implanted in the intended location. The medtronic microcatheter was pushed forward through the pipeline flex in order to recapture the pushwire, but the pushwire could not be pulled back. The physician stated that the pushwire was coming back through the microcatheter without the distal pushwire tip. The physician proceeded to pull back on the phenom microcatheter with the separated distal pushwire tip inside it successfully to the point of the phenom plus at which point, both the catheters were pulled back at the same time along with the separated distal pushwire tip. Once the separated distal pushwire tip was pulled back to the point of the femoral artery, it was removed with the medtronic stent. Following removal of the distal pushwire tip, the physician noticed a portion of the proximal flow diverter on the anterior side that they wanted to balloon angioplasty. This was accomplished successfully by way of the left femoral artery. Post procedural angiography showed successful medtronic flow diverter placement. The patient was undergoing embolization treatment of an unruptured saccular aneurysm with unknown dimensions located in the left internal carotid artery (ica). The aneurysm was previously treated with lvis coil assist stent. The distal and proximal landing zone was 3. 8mm x 4. 09mm. The patient¿s vasculature was minimal in tortuosity. The patient was on dual antiplatelet therapy. It was reported that the pushwire was stuck during retraction. There was no damage observed on the microcatheter, but he pushwire was damaged. The capture coil was not damaged during removal. There are no images for review. Ancillary devices: synchro standard guidewire, phenom plus (my19-046) and phenom 027 (ju19-034) microcatheter, neuron max guide catheter.
 
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Brand NamePIPELINE FLEX
Type of DeviceLASER THERAPY PRODUCT
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10187642
MDR Text Key197594656
Report Number2029214-2020-00588
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-18
Device Catalogue NumberPED-400-18
Device Lot NumberA889033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/24/2020 Patient Sequence Number: 1
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